Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidaemia

European Heart Journal

Volumn 26, Issue 9, 2005, Pages 897-905

  Farnier, Michel ^a   Freeman, Mason W ^b   Macdonell, Geraldine ^c   Perevozskaya, Inna ^c   Davies, Michael J ^c   Mitchel, Yale B ^c   Gumbiner, Barry ^c  

^a Point Medical   (France)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Cholesterol absorption inhibition; Ezetimibe; Fenofibrate; LDL particle size; Lipoproteins

Indexed keywords

ALANINE AMINOTRANSFERASE; APOLIPOPROTEIN B; ASPARTATE AMINOTRANSFERASE; CREATINE KINASE; CREATININE; EZETIMIBE; FENOFIBRATE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; TRIACYLGLYCEROL;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALLERGY; ANGIONEUROTIC EDEMA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIARY TRACT DISEASE; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY RISK; CREATINE KINASE BLOOD LEVEL; CREATININE BLOOD LEVEL; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; GALLBLADDER DISEASE; GASTROINTESTINAL DISEASE; HUMAN; HYPERLIPIDEMIA; HYPERTRIGLYCERIDEMIA; ISCHEMIC HEART DISEASE; LIPOPROTEIN BLOOD LEVEL; LIVER DYSFUNCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MUSCLE DISEASE; MUSCULOSKELETAL DISEASE; MYOPATHY; NON INSULIN DEPENDENT DIABETES MELLITUS; PARALLEL DESIGN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; TRIACYLGLYCEROL BLOOD LEVEL;

ADOLESCENT; ADULT; AGED; ANTILIPEMIC AGENTS; AZETIDINES; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; HYPERLIPIDEMIAS; LIPIDS; MALE; MIDDLE AGED; PROCETOFEN; TREATMENT OUTCOME;

EID: 18744365508     PISSN: 0195668X     EISSN: None     Source Type: Journal    
DOI: 10.1093/eurheartj/ehi231     Document Type: Article

References (26)

1. Durrington P. Dyslipidaemia. Lancet 2003;362:717-731.
2. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA 2001;285:2486-2497.
3. Fazio S, Linton MF. The role of fibrates in managing hyperlipidaemia: mechanisms of action and clinical efficacy. Curr Atheroscler Rep 2004;6:148-157.
4. Product Information. TRICOR (fenofibrate tablets). February, 2003. North Chicago, IL, Abbott Laboratories.
5. Elisaf M. Effects of fibrates on serum metabolic parameters. Curr Med Res Opin 2002;18:269-276.
6. Wierzbicki AS, Mikhailidis DP, Wray R, Schacter M, Cramb R, Simpson WG, Byrne CB. Statin-fibrate combination: therapy for hyperlipidaemia: a review. Curr Med Res Opin 2003;19:155-168.
7. Farmer M. Combination therapy with an HMG-CoA reductase inhibitor and a fibric acid derivative: a critical review of potential benefits and drawbacks. Am J Cardiovasc Drugs 2003;3:169-178.
8. Shek A, Ferrill MJ. Statin-fibrate combination therapy. Ann Pharmacother 2001;35:908-917.
9. van Heek M, France CF, Compton DS, McLeod RL, Yumibe NP, Alton KB, Sybertz EJ, Davis HR Jr. In vivo metabolism-based discovery of a potent cholesterol absorption inhibitor, SCH58235, in the rat and rhesus monkey through the identification of the active metabolites of SCH48461. J Pharmacol Exp Ther 1997;283:157-163.
10. Knopp RH, Gitter H, Truitt T, Bays H, Manion CV, Lipka LJ, LeBeaut AP, Suresh R, Yang B, Veltri EP. Effects of ezetimibe, a new cholesterol absorption inhibitor, on plasma lipids in patients with primary hypercholesterolemia. Eur Heart J 2003;24:729-741.
11. Dujovne CA, Ettinger MP, McNeer JF, Lipka LJ, LeBeaut AP, Suresh R, Yang B, Veltri EP. Efficacy and safety of a potent new selective cholesterol absorption inhibitor, ezetimibe, in patients with primary hypercholesterolemia. Am J Cardiol 2002;90:1092-1097.
12. Bays HE, Moore PB, Drehobl MA, Rosenblatt S, Toth PD, Dujovne CA, Knopp RH, Lipka LJ, LeBeaut AP, Yang B, Mellars LE, Cuffie-Jackson C, Veltri EP. Effectiveness and tolerability of ezetimibe in patients with primary hypercholesterolemia: pooled analysis of two phase II studies. Clin Ther 2001;23:1209-1230.
13. Zhu Y, Statkevich P, Kosoglou T, Zambas D, Patrick J, Cayen MN, Batra V. Effect of ezetimibe (SCH 58235) on the activity of drug metabolizing enzymes in vivo. (Abstract). Clinical Pharmacol Ther 2000;62:152.
14. Kosoglou T, Statkevich P, Fruchart JC, Pember LJC, Reyderman L, Cutler DL, Guillaume M, Maxwell SE, Veltri EP. Pharmacodynamic and pharmacokinetic interaction between fenofibrate and ezetimibe. Curr Med Res Opin 2004;20:1197-1207.
15. Ballantyne CM, Olsson AG, Cook TJ, Mercuri MF, Pedersen TR, Kjekshus J. Influence of low high-density lipoprotein cholesterol and elevated triglyceride on coronary heart disease events and response to simvastatin therapy in 45. Circulation 2001; 104:3046-3051.
16. Vakkilainen J, Steiner G, Ansquer JC, Aubin F, Rattier S, Foucher C, Hamsten A, Taskinen MR. Relationships between low-density lipoprotein particle size, plasma lipoproteins, and progression of coronary artery disease: the Diabetes Atherosclerosis Intervention Study (DAIS). Circulation 2003;107:1733-1737.
17. Frost PH, Havel RJ. Rationale for use of non-high-density lipoprotein cholesterol rather than low-density lipoprotein cholesterol as a tool for lipoprotein cholesterol screening and assessment of risk and therapy. Am J Cardiol 1998;81:26B-31B.
18. Farnier M, Salko T, Isaacsohn JL, Troendle AJ, Dejager S, Gonasun L. Effects of baseline level of triglycerides on changes in lipid levels from combined fluvastatin + fibrate (bezafibrate, fenofibrate, or gemfibrozil). Am J Cardiol 2003;92:794-797.
19. Grundy SM, Vega GL, Yuan Z, Battisti WP, Brady WE, Palmisano J. Effectiveness and tolerability of simvastatin plus fenofibrate for combined hyperlipidaemia (The SAFARI Trial). Am J Cardiol 2005; 95:462-468.
20. Athyros VG, Papageorgiou AA, Athyrou W, Demitriadis DS, Kontopoulos AG. Atorvastatin and micronized fenofibrate alone and in combination in type 2 diabetes with combined hyperlipidaemia. Diabetes Care 2002;25:1198-1202.
21. Kiortsis DN, Millionis H, Bairaktari E, Elisaf MS. Efficacy of combination of atorvastatin and micronised fenofibrate in the treatment of severe mixed hyperlipidaemia. Eur J Clin Pharmacol 2000;56:631-635.
22. Vega GL, Ma PT, Cater NB, Filipchuk N, Meguro S, Garcia-Garcia AB, Grundy SM. Effects of adding fenofibrate (200 mg/day) to simvastatin (10 mg/day) in patients with combined hyperlipidaemia and metabolic syndrome. Am J Cardiol 2003;91:956-960.
23. Liamis G, Kakafika A, Bairaktari E, Miltiadous G, Tsimihodimos V, Goudevenos J, Achimastos A, Elisaf M. Combined treatment with fibrates and small doses of atorvastatin in patients with mixed hyperlipidaemia. Curr Med Res Opin 2002;18:125-128.
24. Kontopoulos AG, Athyros VG, Papageorgiou AA, Hatzikonstandinou HA, Mayroudi MC, Boudoulas H. Effects of simvastatin and ciprofibrate alone and in combination on lipid profile, plasma fibrinogen and low density lipoprotein particle structure and distribution in patients with familial combined hyperlipidaemia and coronary artery disease. Coron Artery Dis 1996;7:843-850.
25. Vakkilainen J, Steiner G, Ansquer JC, Perttunen-Nio H, Taskinen MR. Fenofibrate lowers plasma triglycerides and increases LDL particle diameter in subjects with type 2 diabetes. Diabetes Care 2002; 25:627-628.
26. Armstrong SC, Cozza KL, Sandson NB. Six patterns of drug-drug interactions. Psychosomatics 2003;44:255-258.